Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC
- Conditions
- CarcinomaSmall Cell Lung Cancer
- Interventions
- Procedure: Drug-eluting beads bronchial arterial chemoembolizationProcedure: Intravenous chemotherapy
- Registration Number
- NCT06364046
- Lead Sponsor
- The Central Hospital of Lishui City
- Brief Summary
This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 56
- Age more than 18 years old, regardless of gender;
- SCLC diagnosis based on histopathology according to the Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 edition);
- TNM stage II-IV;
- ECOG PS score ≤2;
- Predicted survival time more than 3 months;
- Provision of signed informed consent.
- Previous interventional therapies such as iodine seed implantation (within the past six months), ablation, BACE, or immunotherapy;
- Concurrent presence of other incurable malignant tumors;
- White blood cell count less than 3×10^9/L, neutrophil absolute count less than 1.5×10^9/L, neutrophil/lymphocyte ratio equal to or greater than 3, platelet count less than 50×10^9/L, hemoglobin concentration less than 90 g/L;
- Hepatic and renal insufficiency (creatinine level exceeding 176.8μmol/L); Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels more than twice the upper limit of normal;
- Uncorrectable coagulopathy or concurrent active hemoptysis;
- Complicated with active infection requiring antibiotic treatment;
- Uncontrolled hypertension, diabetes, or cardiovascular disease;
- Allergy to contrast agents;
- Women who are pregnant or lactating.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab Drug-eluting beads bronchial arterial chemoembolization - Drug-eluting Beads Bronchial Arterial Chemoembolization Combined with Serplulimab Serplulimab - Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab Intravenous chemotherapy - Irinotecan Single-agent Intravenous Chemotherapy Combined with Serplulimab Serplulimab -
- Primary Outcome Measures
Name Time Method Objective response rate Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria at 1 month, 3 months, and 6 months , assessed up to 12 months Evaluation index of clinical efficacy of anticancer drugs.
- Secondary Outcome Measures
Name Time Method The incidence of adverse events and serious adverse events Time Frame: From date of randomization to every follow-up time, assessed up to 2 years. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Progression Free Survival The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years The most common primary endpoint in cancer trials.
Time to tumor untreatable progression The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months. End point of antitumor drug trial.
Eastern Cooperative Oncology Group Score The patient's performance status score is divided into 6 grades. The lowest grade is 0, and the highest grade is 5. The patient's physical state deteriorates as the grade rises,assessed up to 2 years.. Time Frame: From pre-procedure to every follow-up time, assessed up to 2 years.
Recurrence rate of hemoptysis From date of randomization to every follow-up time, assessed up to 2 years. Hemoptysis occurs again
Pain assessment From date of randomization to every follow-up time, assessed up to 2 years. Visual Analogue Scale/Score.The tool is a 10 cm long roving ruler with 11 scales ranging from 0 to 10. A score of 0 means no pain, and a score of 10 means unbearable pain. The higher the score, the more severe the pain
Overall Survival Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive. The best efficacy endpoint in cancer clinical trials.
Tumor biomarkers From pre-procedure to every follow-up time, assessed up to 2 years. carcinoembryonic antigen
Disease Control Rate Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months. Evaluation index of clinical efficacy of anticancer drugs
Duration of Overall Response The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months Evaluation index of clinical efficacy of anticancer drugs.
Quality of life Questionare-Core score From date of randomization to every follow-up time, assessed up to 2 years. The European Organization for Reasearch and Treatment of Cancer Quality of life Questionare-Core score. All items and subscales were converted from 0 to 100, with higher scores indicating better overall quality of life.
Trial Locations
- Locations (1)
Lishui central hospital
🇨🇳Lishui, Zhejiang, China